Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol

• Published in: Contemporary clinical trials communications Vol. 29; p. 100994
• Main Authors: Cucciare, Michael A., Hagedorn, Hildi J., Bounthavong, Mark, Abraham, Traci H., Greene, Carolyn J., Han, Xiaotong, Kemp, Lakiesha, Marchant, Kathy, White, Penny, Humphreys, Keith
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01.10.2022; Elsevier
• Subjects: Benzodiazepine dependence; Digital; Protocol; Self-management; Smartphone app; Veterans; Self-management; Digital; Protocol; Veterans; Smartphone app; Benzodiazepine dependence
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2022.100994

Long-term benzodiazepine dependence carries significant health risks which might be reduced with low-cost patient self-management interventions. A booklet version of one such intervention (Eliminating Medications Through Patient Ownership of End Results; EMPOWER) proved effective in a Canadian clinical trial with older adults. Digitizing such an intervention for electronic delivery and tailoring it to different populations could expand its reach. Accordingly, this article describes the protocol for a randomized controlled trial to test the effectiveness of an electronically-delivered, direct-to-patient benzodiazepine cessation intervention tailored to U.S. military veterans. Design: Two-arm individually randomized controlled trial. US Veterans Health Administration primary care clinics. Primary care patients taking benzodiazepines for three or more months and having access to a smartphone, tablet or desktop computer. Participants will be randomized to receive either the electronically-delivered EMPOWER (EMPOWER-ED) protocol or asked to continue to follow provider recommendations regarding their benzodiazepine use (treatment-as-usual). The primary outcomes are complete benzodiazepine cessation and 25% dose reduction, assessed using administrative and self-report data, between baseline and six-month follow-up. Secondary outcomes are self-reported anxiety symptoms, sleep quality, and overall health and quality of life, measured at baseline and 6-month follow-up, and benzodiazepine cessation at 12-month follow-up. This randomized controlled trial will evaluate whether the accessibility and effectiveness of a promising intervention for benzodiazepine cessation can be improved through digitization and population tailoring.